PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG1860BPSRecalls & reported problems
Cordis US Corp. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032038321), received between May 25, 2021 and May 25, 2021 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K033394); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A PROCEDURE WITH 80CM PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON .035" 18 X 60 OPTA PRO BALLOON EXPANDABLE STENT DELIVERY SYSTEM (SDS) APPROXIMATELY 15 YEARS AGO AND ABOUT A YEAR AFTER, GOT A BRAIN ANEURYSM. THE PATIENT BELIEVED THAT THE DECOMPOSING STENT WAS THE CAUSE OF HER BRAIN ANEURYSM. HER CHIEF COMPLAINT WAS THAT SHE GOT THE BRAIN ANEURYSM DUE TO THE STENT "BREAKING DOWN" AND SHE HAD REPORTED THIS TO HER PHYSICIAN. SHE STATED THAT HER PHYSICIAN MENTIONED THAT THERE WAS NOT ENOUGH RESEARCH ON THIS FOR THE BRAIN ANEURYSM. THE PATIENT WANTED TO KNOW THE MATERIAL COMPOSITION OF THE STENT, BALLOON, AND GUIDEWIRE FOR PALMAZ GENESIS ON OPTA PRO AND THE STENT COMPOSITION OF THE SMART CONTROL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Aneurysm
MAUDE report 11877936 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K033394. One submission often covers many models, so check the product and lot details in each record.
- Z-1363-2022 · May 20, 2022 · Open, ClassifiedPALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page